← FDA DRUG APPROVALS

FDA NDA · NDA022038

DIVIGEL

estradiol

Sponsor: VERTICAL PHARMS

APPLICATION
NDA022038
TYPE
NDA
ORIGINAL APPROVAL
2007-06-04
LATEST ACTION
2026-02-12
ROUTE
TOPICAL, TRANSDERMAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

DIVIGEL · ReferencePrescription
ESTRADIOL 0.1% (1.25GM/PACKET) · GEL · TRANSDERMAL
DIVIGEL · ReferencePrescription
ESTRADIOL 0.1% (1GM/PACKET) · GEL · TRANSDERMAL
DIVIGEL · ReferencePrescription
ESTRADIOL 0.1% (0.25GM/PACKET) · GEL · TRANSDERMAL
DIVIGEL · ReferencePrescription
ESTRADIOL 0.1% (0.75GM/PACKET) · GEL · TRANSDERMAL
DIVIGEL · ReferencePrescription
ESTRADIOL 0.1% (0.5GM/PACKET) · GEL · TRANSDERMAL

Approval history

2026-02-12Labeling · Supplement 17 · standard — Label ↗AP
2025-04-29Labeling · Supplement 14 · standard — Label ↗AP
2024-02-15Labeling · Supplement 12 · standard — Letter ↗AP
2023-05-23Labeling · Supplement 10 · standard — Letter ↗AP
2019-12-12Labeling · Supplement 5 · standard — Letter ↗AP
2019-12-12Efficacy · Supplement 6 · standard — Letter ↗AP
2018-08-17Efficacy · Supplement 4 · standard — Letter ↗AP
2017-11-01Labeling · Supplement 3 · standard — Label ↗AP
2012-05-29Labeling · Supplement 2 · standard — Letter ↗AP
2007-06-04Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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